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Parenteral Drug Association Connecting People, Science and Regulation ®

Job Description

Position: Senior Training Specialist
Department: Education
Reports To: Senior Director, Education
Status: Exempt, Full Time

Summary Description

Primary Goal: This position is responsible for the management and execution of PDA’s education department course catalog.  This includes planning, designing, development, and coordination of training courses.  This position works collaboratively with instructors and staff to develop courses and eLearning modules and provide instructional design assistance including web-based applications and digital media. This position requires hands on participation in course activities when necessary.  Experience within the pharmaceutical manufacturing industry preferred.

Duties & Responsibilities

  • Course Development and Delivery
    • Works with industry and regulatory professionals, and various groups to develop new educational and/or training courses consistent with their needs.
    • Partners with subject matter experts through root cause and performance gap analysis to develop community-leading courses which provide educational content that is current and unique to PDA, emphasizing content that is new and/or updated based on trends and changes in manufacturing processes
    • Develops a continuum of courses for all stages of a career in communities targeted by the course.
    • Design and develop completely custom learning deliverables, based on SME interviews, core content and/or interviews with published leadership experts.
    •  Incorporate industry best practices and techniques in learning products.
    • Assist in the assessment and evaluation of the effectiveness of existing and newly created materials and programs.
    • Develop storyboarding for learning content.
    • Deliver technical training programs with support and expertise with consideration to a wide range of learning styles as well as the participants' operations environment.
  • Course Management
    • Develop, establish and maintain compliant quality assurance systems, processes and procedures in support of course delivery.
    • Manage the master course schedule by reviewing PDA and competitor organization event schedules for potential conflicts and selects events to minimize competitive conflicts.
    • Participates as a faculty member in the presentation of various courses as applicable and necessary.
    • Continually evaluates courses for standards, including quality performance and specifications.
    • Audits, manages and directs courses to ensure appropriateness and exclusivity of content for target audiences.
    • Maintains complete and up-to-date electronic and paper course records in compliance with standards set by Continue Education accreditation requirements and PDA. 
  • Business Development/Marketing Support
    • Present to and consult with industry professionals on business trends with a view to developing new training or revising existing training offerings.
    • Provides and edits content on all marketing media such as the Connector, website, course brochures and course catalog.
    • Provides content for courses to be published on the PDA website.
    • Writes articles for PDA Letter.
    • Prepares and presents verbal and/or written communications concerning education courses offered by TRI.
  • Department Leadership
    • Develop, track and regularly report metrics around key performance indicators (KPIs).
    • Facilitate resolution of quality and operational issues in a timely manner. Coordinate communication with internal cross functional teams for quality issues.
    • Coordinate communication with internal cross functional teams for quality issues.
    • Lead or represent department on cross functional project teams with internal stakeholders (Marketing, Registration, Science and Regulatory, Senior Management) to achieve departmental and company objectives
    • Provide exceptional leadership skills to the organization including hiring, mentoring and developing staff.

Education/Experience

A BS/BA degree or equivalent in biological, chemical or physical science, and a minimum of 7 to 10 years in the pharmaceutical industry in the areas of aseptic manufacturing, biological, chemical or physical sciences required. Course and course content development and presentation, and/or marketing of a specific product preferred.

Competency: To perform the essential functions of this position and the job successfully, an individual should demonstrate the following competencies.

Qualifications:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Ability to organize, prioritize and handle multiple, time-sensitive tasks; strong oral and written communication and interpersonal skills; must be team oriented and willing to assist others with critical deadlines as needed; must understand pharmaceutical laboratory and manufacturing processes and systems.

Demonstrated familiarity with commonly used concepts, practices and procedures within the training industry such as the ADDIE and SAM models

Language Ability

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; ability to write speeches and articles for publication that conform to prescribed style and format; ability to effectively present information to top management, public groups, and/or boards of directors.

Math Ability

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Must be able to deal with ambiguity and analyze and determine appropriate courses of actions. Must possess the ability to summarize and analyze instructor and course evaluations, as well as more general surveys and questionnaires

Computer Skills

Proficiency in Microsoft Word, Excel and PowerPoint. 

Certificates and Licenses

Not Applicable

Supervisory Responsibilities

Not Applicable

Special Requirements

Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ability to independently ascend and descend stairs;
  • Ability to independently reach, twist and bend;
  • Ability to independently remain stationery for extended periods of time; and
  • Ability to independently lift up to 30 pounds when required by work assignment.